Adverse Effects of ATG/ALG Therapy in Aplastic Anemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ATG/ALG.
- Who it may be relevant to
- Registry conditions: Aplastic Anaemia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study on the Dynamics and Grading Criteria Construction of Adverse Reactions to ATG/ALG Therapy in Aplastic Anemia
Overview
This prospective, single-center, observational cohort study aims to systematically observe and describe the clinical characteristics of adverse reactions in patients with aplastic anemia undergoing ATG (Anti-Thymocyte Globulin) /ALG (Anti-Lymphocyte Globulin) treatment, providing a data foundation for the development of relevant management strategies. This study plans to enroll 200 aplastic anemia patients undergoing ATG/ALG treatment
Interventions
- Drug ATG/ALG
Participants will receive ATG/ALG according to standard dosing protocols as per clinical guidelines. During treatment, we will monitor and document any adverse reactions, including their type, severity, duration, and any necessary interventions or changes in treatment plan.
Primary outcome measures
- Percentage of patients with serum sickness and its severity [Time frame: Within 4 weeks after ATG/ALG infusion]
Secondary outcome measures (2)
- Percentage of patients with liver and kidney function damage and its severity [Time frame: During ATG/ALG infusion (typically from d1 to d6) and within 4 weeks after ATG/ALG infusion]
- Percentage of patients with infusion reaction and its severity [Time frame: During ATG/ALG infusion(typically from d1 to d6)]
Eligibility criteria
Inclusion criteria
- Meet the diagnostic criteria for aplastic anemia (Camitta criteria);
- Receiving ATG/ALG immunosuppressive therapy for the first time;
Exclusion criteria
- Previously received hematopoietic stem cell transplantation;
- Aplastic anemia patients receiving ATG/ALG as part of transplant conditioning regimen;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Regenerative Medicine Center and Red Blood Cell Disorders Center — Tianjin
Identifiers
NCT: NCT07461116 · AA-ATG/ALG-20260108